Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee.

A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.

The primary efficacy variable is the change from baseline to final assessment in the Western Ontario and McMastern University OA index (WOMAC), and Lequesne´s functional index. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

The WOMAC osteoarthritis index is a validated, multidimensional, disease specific, health status measure. It probes clinically important patient relevant symptoms in the areas of pain, stiffness and physical function in patients with hip and/or knee osteoarthritis. It consists of 24 questions in three separated subscales (5 questions on pain subscale, 17 questions on physical function subscales and 2 questions on stiffness subscale), each scored in analog scale from 0 to 10 points (0 representing no pain, 10 representing extreme pain). Each subscale score was weighed 10 points, thus 30 was the maximum punctuation for WOMAC total score.

The Lequesne index is a 10-question interview-style survey given to patients with osteoarthritis of the knee. It has 5 questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and 4 questions about daily activities. The total questionnaire is scored on a 0 to 24 scale, with lower scores meaning less functional impairment.

Eligibility

Ages Eligible for Study:

40 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

age > 40 years

symptomatic evidence of OA in the knee for at least 1 year

radiographic evidence of Kellgren and Lawrence grade II to IV OA of the knee

no intra-articular injection of corticosteroids within the last 3 months

Exclusion Criteria:

any history of adverse reaction to the study drugs

current pregnancy status

uncontrolled hypertension

active infection

undergone surgery/arthroscopy within three months

diagnosis of radiographic OA of Kellgren and Lawrence grade I

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977444